The present invention relates to a method and apparatus for the centralized collection of geographically distributed data. In particular, the invention provides for a method of gathering data that provides interactivity and uses an existing wide area network in the collection of data, while providing high quality data collection with immediate validation of data. Accordingly, the invention is particularly applicable to any enterprise wherein it is useful to collect and maintain data for subsequent study or analysis. It is extremely useful for institutions or businesses wishing to amass data for prospective studies, such as clinical trials for pharmaceuticals.
Previously information gathering and data transmission has taken several forms. For example, an individual or member of a group may be given a questionnaire for completion and asked to deliver the completed questionnaire to a central location for tabulation or other processing.
Information (i.e., data), once obtained, may then be transmitted to a central or primary location in several ways. The data, if on paper, may be mailed or perhaps facsimile transmitted to the central location where it is received and further processed. Using a computer system, the information may be encrypted on a computer diskette and mailed to a central location or transmitted by modem. Data on the diskette is then input to a database, for example, where it is electronically stored for further processing. This type of data gathering has a number of drawbacks. One major problem is that the database must be able to accept information deriving from various diskette styles and from diverse computer types or platforms, or the information can only be gathered in this manner by machines which are compatible in their document processing formats. The only other option is to transmit the computer readable data in a plain ASCII format.
As a result, for any study using a large number of data gathers, such as a clinical trial, the data is usually transmitted in paper form to be read and input to a computer database by another individual.
Over the years, the medical profession has widely used information collection and analysis to determine, for example, if procedures being performed are achieving the desired or expected results. Factors relating to both demographic and clinical data are needed to accurately report on completed procedures. Data ranging from the patient information such as age, weight, gender and so on, must be known as well as other information such as the symptoms experienced by the patient, methods used to perform the procedure, tools used, biopsies performed, measurements taken as well as other more detailed clinical information.
In some instances, obtaining information regarding medical procedures can be relatively straight forward. For example, due to the high cost of equipment and staff involved, heart transplants are performed at relatively few medical facilities. Thus, these facilities can be more easily networked to enable access to a central database where results and demographics can be collected and processed. For example, it is physically possible and not too onerous to visit each site where heart transplants are performed and install computer software, and provide training to the hospital staff regarding how to gather and enter the clinical and demographic information into the hospital-based terminals. The information may then be transmitted to a central site via a private wide area network for processing or for inclusion into a database to be available for review and study.
When information must be collected from a great many locations, the above systems are not practical. The cost of installing a private wide area network is typically prohibitive. For instance, many medical procedures are implemented throughout the world, in virtually any hospital or medical operating facility. For example, eye lens replacement (cataract) surgery and gastrointestinal endoscopic procedures are practiced or performed on an xe2x80x9cout-patient,xe2x80x9d same day surgery basis throughout not only the United States, but the world, in facilities such as local or community hospitals or even stand alone out-patient surgical units. Thus, it is impractical and expensive to visit each and every site, install compatible software, and provide training for its use at such a large number of sites. In addition, each upgrade in software would require the same extensive visiting and dissemination. Moreover, the chances of erroneous information being entered into a system are greatly increased as the number of entry sites is expanded.
In addition to the medical community and research centers collecting data for studies, pharmaceutical companies are required to collect data in vast multi-center sites in order to obtain regulatory approval for their drugs. Clinical studies for drug approval require dose ranging and efficacy studies which are usually carried out in sites around the globe such as in the United States, Europe, Canada and Australia. Typically, the pharmaceutical company together with the United States Food and Drug Administration develops the strategy to study the effect of the drug or vaccine. This results in a protocol which is disseminated to all physicians and sites involved in the study. The information is then gathered and recorded by hand in the filling out of a form. These forms, with all of their possible human data entry mistakes and bad handwriting, are then sent to the pharmaceutical company to be rerecorded and entered into a computer as data for statistical analysis.
The gathering of the information at the sites is tedious and is extremely expensive for the pharmaceutical companies. In addition, when there is inaccurate data or unusable data, i.e., invalid data, entire studies can be in jeopardy. Due to the difficulties in obtaining patients for studies, it is imperative to be able to use all the data so as to have a statistically significant result; when data is invalid through errors in recording, studies can be lost.
Accordingly, a need exists for an effective means for gathering geographically distributed data that is valid and will permit the use of the data in either prospective or retrospective studies. In addition, the method or system should make use of existing wide area networks and be compatible with readily available hardware and software so as to provide a cost effective means of gathering the data. Such a means is provided by the method and system of the present invention.
It is therefore a principle object of the invention to provide a method and apparatus for the centralized collection of geographically distributed data.
It is a further object of the invention to solve the above identified problems in the field.
The present invention solves the problems noted above by providing a data gathering, validation/verification and transmission system that may be easily, and at minimal cost, made available to substantially all practitioners in a field regardless of geographic location Moreover, the system is designed to be utilized by even non-computer-literate individuals in the general population.
The present invention provides an interactive method for the centralized collection of geographically distributed data using an existing wide area network. The method accommodates for data being input from diverse computer types and platforms via the use of a universal interactive programming language, such as JAVA(copyright). In addition, the method assures that the collected data is of the highest quality due to immediate validation during the gathering process, and prior to acceptance and storage in the database.
Accordingly, the present invention provides a method for the centralized collection of geographically distributed data comprising: receiving data from the at least one user with the remote site computer; checking the data for validity with the remote site computer; providing the user an opportunity to correct any invalid data found during the checking; transmitting the data to a centralized computer over a transmission medium; receiving and validating the data from the remote site computer at the centralized computer, including comparing the data to data already stored at the centralized computer to determine if it is valid or invalid; if the data from the remote site computer is determined to be invalid, then performing the following until all data is determined to be valid: signaling with the centralized computer to the remote site computer to provide the user an opportunity to correct invalid data; transmitting corrected data from the remote site computer to the centralized computer; and receiving and validating the corrected data from the remote site computer at the centralized computer, including comparing the corrected data to data already stored at the centralized computer to determine if it is valid or invalid; when all data has been determined to be valid, then entering and storing the valid data in a central database at the centralized computer.